HER2 Positive Breast CancerPhase 2NCT03735966
Neoadjuvant Study of Pyrotinib and Trastuzumab Plus Docetaxel and Carboplatin in HER2 Positive Breast Cancer Patients.
A Phase 2 study testing Pyrotinib plus trastuzumab and docetaxel and carboplatin in people with HER2 Positive Breast Cancer, run by Henan Cancer Hospital at 1 site in China.
Trial summary
Pyrotinib is an oral tyrosine kinase inhibitor targeting both HER-1 and HER-2 receptors.This study is a single-arm, prospective, open label clinical study for evaluating the efficacy and safety of neoadjuvant pyrotinib and trastuzumab plus docetaxel given as neoadjuvant treatment in HER2 positive early stage or… Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- HER2 Positive Breast Cancer
- What is being tested?
- Pyrotinib plus trastuzumab and docetaxel and carboplatin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteChina
- Study dates
- 20 Nov 2018to 20 Oct 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- female patients, 18 years ≤ age ≤ 75 years.
- Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-1.
- Histologically confirmed invasive breast cancer（early stage or locally advanced）:Primary tumour greater than 2 cm diameter
- HER2 positive (HER2+++ by IHC or FISH+)
- Life expectancy of more than 3 months
- Known hormone receptor status.
- Required laboratory values including following parameters: ANC: ≥ 1.5 x 10^9/L;Platelet count: ≥ 100 x 10^9/L;Hemoglobin: ≥ 9.0 g/dL;Total bilirubin: ≤ 1.5 x upper limit of normal (ULN);ALT and AST: ≤ 1.5 x ULN (or ≤ 5×ULN in patients with liver metastases);BUN and creatine clearance rate: ≥ 50 mL/min;LVEF: ≥ 50%;QTcF: < 470 ms for female and < 450 ms for male.
- Signed the informed consent form prior to patient entry.
Who cannot join
- metastatic disease (Stage IV) or inflammatory breast cancer.
- Previous or current history of malignant neoplasms, except for curatively treated:Basal and squamous cell carcinoma of the skin,Carcinoma in situ of the cervix.
- clinically relevant cardiovascular disease:Known history of uncontrolled or symptomatic angina, clinically significant arrhythmias, congestive heart failure, transmural myocardial infarction, uncontrolled hypertension ≥180/110);
- Unable or unwilling to swallow tablets.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Neoadjuvant Study of Pyrotinib in Combination With Trastuzumab Plus Docetaxel and Carboplatin in Patients With HER2 Positive Early Stage or Locally Advanced Breast Cancer : a Single-arm,Ahead , Open-label Study
Pyrotinib is an oral tyrosine kinase inhibitor targeting both HER-1 and HER-2 receptors.This study is a single-arm, prospective, open label clinical study for evaluating the efficacy and safety of neoadjuvant pyrotinib and trastuzumab plus docetaxel given as neoadjuvant treatment in HER2 positive early stage or locally advanced breast cancer.
Read the detailed description
Neoadjuvant therapy is the standard treatment for locally advanced breast cancer and is used to reduce tumors to make them operable, and to increase breast-conserving rates. In recent years, the anti-HER2 treatment mode, which is double-blocked by a combination of dual-targeted drugs, has obtained clinical approval in adjuvant therapy and neoadjuvant therapy. Pyrotinib is an oral tyrosine kinase inhibitor targeting both HER-1 and HER-2 receptors. Based on previous clinical studies, we designed the study to explore the possibility of Pyrotinib in combination with Trastuzumab plus Docetaxel given as neoadjuvant treatment in HER2 positive early stage or locally advanced breast cancer.
- Conditions
- HER2 Positive Breast Cancer
- Being tested
- Pyrotinib plus trastuzumab and docetaxel and carboplatin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pyrotinib plus trastuzumab and docetaxel and carboplatinDrug
pyrotinib: 320mg orally daily，6cycles; trastuzumab:8mg/kg iv load followed by 6mg/kg iv 3-weekly for a total of 6cycles; docetaxel:after the biological window, 100mg/m2 for a total of 6 cycles carboplatin:d1 ，AUC 6 iv 3-weekly for a total of 6 cycles
| Study group | Role | What they receive |
|---|---|---|
| Pyrotinib plus trastuzumab and docetaxel and carboplatin | Experimental | Pyrotinib + trastuzumab + docetaxel+carboplatin Receives: Drug: Pyrotinib plus trastuzumab and docetaxel and carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological Complete Response (pCR)
Percentage of Participants With Pathological Complete Response (pCR) at the Time of Surgery evaluated
Measured: through study completion, an average of 1 year
Secondary outcomes (4)
EFS
Event-free survival
Measured: Following surgery until Year 5
DFS
Disease-free Survival
Measured: Following surgery until Year 5
DDFS
Distance Disease-free Survival
Measured: Following surgery until Year 5
ORR
Objective Response Rate
Measured: Baseline up to cycle 4 (assessed at Baseline, at the time of pre-surgery)up to approximately 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2018
- Study start20 Nov 2018
- Primary completion20 Oct 2020
- Study completion20 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HER2 Positive Breast CancerStudies of the same condition, open and under way.
- More trials run by Henan Cancer HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henan Cancer Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Zhenzhen Liu, Principal investigator, Study Principal Investigator Henan Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03735966
- Sponsor's protocol ID
- HR-NeoBC-HN002
- Status last verified
- Apr 2020
- First submitted
- 5 Nov 2018
- Last updated
- 1 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvant Study of Pyrotinib in Combination With Trastuzumab Plus Docetaxel and Carboplatin in Patients With HER2 Positive Early Stage or Locally Advanced Breast Cancer : a Single-arm,Ahead , Open-label Study
- ClinicalTrials.gov ID
- NCT03735966
- Acronym / sponsor ID
- HR-NeoBC-HN002
- Conditions
- HER2 Positive Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Henan Cancer HospitalOther government
- Study start
- 20 Nov 2018 (actual)
- Primary completion
- 20 Oct 2020 (actual)
- Study completion
- 20 Oct 2020 (actual)
- First posted
- 8 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Pyrotinib is an oral tyrosine kinase inhibitor targeting both HER-1 and HER-2 receptors.This study is a single-arm, prospective, open label clinical study for evaluating the efficacy and safety of neoadjuvant pyrotinib and trastuzumab plus docetaxel given as neoadjuvant treatment in HER2 positive early stage or locally advanced breast cancer.
Detailed description
Neoadjuvant therapy is the standard treatment for locally advanced breast cancer and is used to reduce tumors to make them operable, and to increase breast-conserving rates. In recent years, the anti-HER2 treatment mode, which is double-blocked by a combination of dual-targeted drugs, has obtained clinical approval in adjuvant therapy and neoadjuvant therapy. Pyrotinib is an oral tyrosine kinase inhibitor targeting both HER-1 and HER-2 receptors. Based on previous clinical studies, we designed the study to explore the possibility of Pyrotinib in combination with Trastuzumab plus Docetaxel given as neoadjuvant treatment in HER2 positive early stage or locally advanced breast cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pyrotinib plus trastuzumab and docetaxel and carboplatin | Experimental | Drug: Pyrotinib plus trastuzumab and docetaxel and carboplatinPyrotinib + trastuzumab + docetaxel+carboplatin |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- female patients, 18 years ≤ age ≤ 75 years.
- Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-1.
- Histologically confirmed invasive breast cancer（early stage or locally advanced）:Primary tumour greater than 2 cm diameter
- HER2 positive (HER2+++ by IHC or FISH+)
- Life expectancy of more than 3 months
Key exclusion criteria (4 listed)
- metastatic disease (Stage IV) or inflammatory breast cancer.
- Previous or current history of malignant neoplasms, except for curatively treated:Basal and squamous cell carcinoma of the skin,Carcinoma in situ of the cervix.
- clinically relevant cardiovascular disease:Known history of uncontrolled or symptomatic angina, clinically significant arrhythmias, congestive heart failure, transmural myocardial infarction, uncontrolled hypertension ≥180/110);
- Unable or unwilling to swallow tablets.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pyrotinib plus trastuzumab and docetaxel and carboplatinpyrotinib: 320mg orally daily，6cycles; trastuzumab:8mg/kg iv load followed by 6mg/kg iv 3-weekly for a total of 6cycles; docetaxel:after the biological window, 100mg/m2 for a total of 6 cycles carboplatin:d1 ，AUC 6 iv 3-weekly for a total of 6 cycles | Drug | Pyrotinib plus trastuzumab and docetaxel and carboplatin |
Primary outcome
Pathological Complete Response (pCR)
Time frame: through study completion, an average of 1 year
Percentage of Participants With Pathological Complete Response (pCR) at the Time of Surgery evaluated
4 secondary outcomes
EFS
Time frame: Following surgery until Year 5
DFS
Time frame: Following surgery until Year 5
DDFS
Time frame: Following surgery until Year 5
ORR
Time frame: Baseline up to cycle 4 (assessed at Baseline, at the time of pre-surgery)up to approximately 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhenzhen Liu principal investigator
Study Principal Investigator Henan Cancer Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pyrotinib plus trastuzumab and docetaxel and carboplatin in people with HER2 Positive Breast Cancer, run by Henan Cancer Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological Complete Response (pCR) (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2022.